UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019214 |
|---|---|
| Receipt number | R000022209 |
| Scientific Title | Pharyngeal cannulae as a new oxygen delivery method; comparison to nasal vannulae |
| Date of disclosure of the study information | 2015/10/05 |
| Last modified on | 2019/01/24 21:28:03 |
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Basic information
Public title
Pharyngeal cannulae as a new oxygen delivery method; comparison to nasal vannulae
Acronym
Pharyngeal cannulae as a new oxygen delivery method
Scientific Title
Pharyngeal cannulae as a new oxygen delivery method; comparison to nasal vannulae
Scientific Title:Acronym
Pharyngeal cannulae as a new oxygen delivery method
Region
| Japan |
Condition
Condition
Hypoxia during upper gastrointestinal endoscopy in sedated patients
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
During sedation for upper gastrointestinal endoscopy, oxygen supplementation with nasal cannulae (NC) is frequently necessary to prevent hypoxia. A mannequine study we previously performed showed pharyngeal cannulae (PC) provided higher oxygen consentration than NC. This study is aimed to show PC can privide higher oxygen fraction than NC in real patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fraction of inspired oxygen during oxygen delivery via PC or NC, which is mearsured with direct sampling of tracheal gas by cricothyroid ligament puncture catheter
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Oxygen is administrated via a catherter inserted from nose to pharyngeal space at 4 L/min. After preoxygenation (more than 5 minutes), FIO2 is measured for 1 minute by sampling from tracheal catherter. Second measurement is performed in the same way.
Interventions/Control_2
Oxygen is administrated via a nasal cannula at 4L/min. After preoxygenation (more than 5 minutes), FIO2 is measured for 1 minute by sampling from tracheal catherter. Second measurement is performed in the same way.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who were inserted minitracheostomy tubes after extubation of oral endotracheal tubes would be recruited into this study. Participants needs to be awake and be able to understand and consent to this study.
Key exclusion criteria
Exclusion criteria includes patients with anatomical abnormality of nose and pharynx, respiratory diseases, unstable circulatory status, severe hypoxia. In addition, patients who are judged to unsuitable to this study would be also excluded.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shunsuke Takaki |
Organization
Yokohama City University Hospital
Division name
Department of Anesthesiology and Intensive Care Unit
Zip code
Address
3-9, Fukura, Kanazawa-ku Yokohama-shi, Kanagawa, 236-0004, Japan
TEL
81457872918
anesthes@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shunsuke Takaki |
Organization
Yokohama City University Hospital
Division name
Department of Anesthesiology and Intensive Care Unit
Zip code
Address
3-9, Fukura, Kanazawa-ku Yokohama-shi, Kanagawa, 236-0004, Japan
TEL
81457872918
Homepage URL
anesthes@yokohama-cu.ac.jp
Sponsor or person
Institute
Department of Anesthesiology and Intensive Care Unit, Yokohama City University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, Yokohama City University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
横浜市立大学附属病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2015 | Year | 09 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 02 | Day |
Last modified on
| 2019 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022209
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
